Device Classification Name |
Filter, Intravascular, Cardiovascular
|
510(k) Number |
K112497 |
Device Name |
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT |
Applicant |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Applicant Contact |
Joni Creal |
Correspondent |
C.R. BARD, INC. |
1625 WEST 3RD ST. |
TEMPE,
AZ
85281 -1740
|
|
Correspondent Contact |
Joni Creal |
Regulation Number | 870.3375
|
Classification Product Code |
|
Date Received | 08/29/2011 |
Decision Date | 10/24/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|